New Year Doesn’t Change FDA ‘Old’ 483 Focus
Looks like the FDA missed the memo that it’s a new year. If recent 483s are any indicator, the agency hasn’t made any serious New Year’s resolutions about changing its enforcement focus.
In fact, we could turn to two ancient FDA beat reporters, William Shakespeare and WIlliam Faulkner, to perhaps best sum up the most effective way to predict the FDA’s enforcement strategy in 2013.
In The Tempest, Shakespeare tells us, “What’s past is prologue.”
Or you could go with Faulkner in Requiem for a Nun with its famous observation, “The past is never dead. It’s not even past.”
You could also skip the literary quotes and take a look at a recent crop of 483s yourself.
If you fancy yourself a speed reader, you might save time with a quick skim and quickly get the flavor of FDA’s top offenders, if you will. You’ll see the same terms and key words come up over and over in FDA 483s of late:
- Procedures for receiving, reviewing and evaluating complaints not adequately established
- Procedures for quality audits have not been adequately established
- Procedures not established for quality audits.
If you’ve got a bit more time, we think it’s worth it spending some of it taking a closer look at the agency’s most recent enforcement actions. In fact, an examination of a single month, October 2012, gives us many clues about where FDA inspectors are looking when they come calling.
In late October 2012, the agency hit D.E. Hokanson Inc., a vascular diagnostic product maker based in Bothell, WA, with observations the company had not adequately put procedures in place to review, receive and evaluate complaints by a formally designated unit.
Earlier that month, the FDA hit SRI Surgical, a medical device specifications developer in Maitland, FL, for failure to adequately establish CAPA procedures.
A day earlier, Malem Medical, a device manufacturer based in the UK with offices in Maryland, was observed to have not adequately established procedures for quality audits — or adequately trained personnel.
On October 1 last year, the FDA hit Danmar Products, a device manufacturer in Detroit, also for not having established quality audit procedures — or adequately trained personnel.
It’s worth noting that each of these 483s came from a different FDA Inspector. In other words, this focus is wider than a single Inspector with a pet peeve.
The release of 483s lags a few months, so it is possible that the next crop of FDA 483s will show a radically different focus from FDA inspectors.
But don’t count on it. Neither William would.